Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.

Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia.

This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Anxiety; Pain, Procedural; Gender; Nociceptive Pain; Pupillary Light Reflex Lost
• Intervention / Treatment: Device: CE marked medical device; Device: Algometer; Procedure: Comparator

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Maria Rosa Ballester, PhD; Email: mballesterv@santpau.cat
    • Contact: Phone Number: +34935537855

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects of both sexes (balanced)
2. Caucasian race
3. Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
4. Body weight within the normal range (Quetelet index: 19-30)
5. Clinical history, physical examination and vital signs within normality
6. Free acceptance to participate, with written informed consent

Exclusion Criteria:

1. Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption> 40 gr / day for men or> 24 gr / day for women)
2. Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
3. Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
4. Pregnancy (β-hCG test).
5. Menstruation and / or dysmenorrhea on the day of the study
6. Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
7. Pupillary diameter ≥ 5mm
8. Smokers or ex-smokers <6 months.
9. Have participated in a clinical trial in the 3 months prior to the start of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: threshold stimulation (tetanic)	Device: CE marked medical device; Tetanic stimulation
Experimental: upper threshold stimulation (tetanic)	Device: CE marked medical device; Tetanic stimulation
Experimental: threshold stimulation (pressure)	Device: Algometer; Pressure stimulation
Experimental: upper threshold stimulation (pressure)	Device: Algometer; Pressure stimulation
Placebo Comparator: non nociceptive procedure (fine touch)	Procedure: Comparator; Non-nociceptive procedure (fine touch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®	Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Nociceptive Pain
• Other Study ID Numbers: IIBSP-PUP-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No